Systems and Methods for the Treatment of Oral and Systemic maladies in Animals Using Electrical Current

ABSTRACT

Systems and methods for the concurrent treatment of multiple oral diseases and defects while promoting general oral hygiene utilizing electricity are provided for non-human animals. Electrodes are used to deliver an electrical current to the gingival tissues of a mouth in order to achieve a number of therapeutic, prophylactic, and regenerative benefits. These benefits include killing oral microbes, increasing oral vasodilation, reducing oral biofilm, improving oral blood circulation, reversing oral bone resorption, promoting oral osteogenesis, treating gum recession, and fostering gingival regeneration. Other benefits include the treatment of gingivitis, periodontitis, and oral malodor, and other systemic diseases correlated with oral pathogens.

RELATED APPLICATIONS

This application is a continuation of co-pending U.S. patent applicationSer. No. 16/272,695, filed 11 Feb. 2019, entitled “Systems and Methodsfor the Treatment of Oral and Systemic Maladies in Animals UsingElectrical Current”, which is a continuation of patented U.S. patentapplication Ser. No. 15/638,903, filed 30 Jun. 2017, entitled “Systemsand Methods for the Treatment of Oral and Systemic Maladies in AnimalsUsing Electrical Current”, now U.S. Pat. No. 10,201,698, issued 12 Feb.2019, which is a continuation of Ser. No. 14/591,629, filed 7 Jan. 2015,entitled “Systems and Methods for the Treatment of Oral and SystemicMaladies in Animals Using Electrical Current,” now abandoned, whichclaims the benefit of now expired provisional patent application Ser.No. 61/924,381, filed 7 Jan. 2014, and entitled “Systems and Methods forthe Treatment of Oral and Systemic Maladies in Animals Using ElectricalCurrent,” now expired, all such patent applications being incorporatedherein by reference in their entireties.

BACKGROUND

This invention relates to a method of concurrently promoting generaloral hygiene in non-human animals, treating periodontal diseases such asgingivitis and periodontitis, killing oral microbes includingcavity-causing bacteria, reducing oral biofilms, increasing blood flowin oral tissues, increasing salivation, promoting gingival tissueregeneration, fostering osteogenesis in the boney structures of theteeth, mouth and related areas, treating systemic diseases associatedwith oral bacteria, and treating other periodontal and oral maladiesthrough the non-invasive application of weak direct current electricityto the surfaces in the oral cavity, and it also relates to an apparatussuitable for providing direct current electricity for these therapeutic,prophylactic, and regenerative effects.

Periodontal disease has been identified as a risk factor for varioussystemic diseases by dentists, physicians, and veterinarians. Includedin these diseases are cardiovascular disease, adverse pregnancyoutcomes, and diabetes with newfound evidence supporting its associationwith pancreatic diseases and arthritis. While many of the studiesestablish correlation between the presence of periodontal disease andthese systemic conditions, causation, with most of these conditions, isstill a subject of ongoing research. A few of the biological mechanismswhich have been proposed as to how oral bacteria stemming fromperiodontal disease can cause systemic disease are as followed:

1. Direct effect of oral infections: Oral microbes and their byproductscan gain systemic access via the circulatory system through travelingthrough compromised tissue and inflamed periodontium in the oral cavity.In gaining systemic access, oral microbes have the potential to directlyinfluence subclinical mediators of various systemic diseases.

2. Inflammation: People with periodontal disease have elevated levels ofsystemic inflammatory markers due to the burden of increased levels oforal bacteria. Treatment for periodontal disease has been reported todecrease systemic inflammation levels.

3. Cross-reactivity: The progression of systemic diseases can beaccelerated by the immune response to bacterial heat-shock proteinscreating antibodies that cross-react with innate heat shock proteinsexpressed on cells of the damaged tissues.

SUMMARY OF THE INVENTION

The present invention relates to systems and methods for aiding overalloral health of a non-human animal, and more particularly to treatingperiodontal diseases such as gingivitis and periodontitis, killing oralmicrobes including cavity-causing bacteria, reducing oral biofilms,increasing blood flow in oral tissues, increasing salivation, promotinggingival tissue regeneration, fostering osteogenesis in the boneystructures of the teeth, mouth and related areas, treating systemicdiseases associated with oral bacteria, and treating other periodontaland oral maladies through the non-invasive application of weak directcurrent electricity to the surfaces in the oral cavity.

One aspect of the present invention includes a method including thesteps of providing a device and delivering the device to a mouth of anon-human animal. The device preferably includes a body (which may besubstantially hourglass shaped, generally) having an external surfaceformed of a first electrically insulative resilient material and a firstand second electrically conductive resilient material, wherein the firstelectrically conductive resilient material is in electricalcommunication with a first pole of a power source disposed in the bodyand the second electrically conductive resilient material is inelectrical communication with a second pole of the power source. Whendelivered to the mouth, an electrical current sourced (directly orindirectly) from the power source is delivered between the first andsecond electrically conductive resilient material for a predeterminedduration of time to reduce a bacterial concentration within the mouth.

According to another aspect of an embodiment of a method according tothe present invention, the electrical current is selected from the groupconsisting of alternating current and direct current, and can either beconstantly applied or pulsed on and off.

According to still another aspect of an embodiment of a method accordingto the present invention, the electrical current is provided at acurrent level of between about 50 microamps (μA) and about 500 microamps(μA), such as about 50 microamps to about 250 microamps, or about 100microamps.

According to still another aspect of an embodiment of a method accordingto the present invention, the first electrically insulative resilientmaterial is disposed between (and may surround or encircle each of) thefirst electrically conductive resilient material and the secondelectrically conductive resilient material. The first electricallyconductive resilient material and the second electrically conductiveresilient material may be formed from the same composition of materialas each other. The first electrically insulative resilient material hasa first durometer hardness and the first and second electricallyconductive resilient material have a second durometer hardness. Thefirst durometer hardness is preferably substantially the same as thesecond durometer hardness.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of a device accordingto the present invention.

FIG. 2 is a front elevation view of the embodiment shown in FIG. 1.

FIG. 3 is a right side elevation view of the embodiment of FIG. 1.

FIG. 4 is a top plan view of the embodiment of FIG. 1.

FIG. 5 is a bottom plan view of the embodiment of FIG. 1.

FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 2.

FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. 3.

FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 4.

FIG. 9 is a schematic view of an embodiment of an electrical circuitaccording to the present invention.

FIG. 10 is a front elevation view of a second embodiment of a deviceaccording to the present invention.

FIG. 11 is a cross-sectional view taken through the center of theembodiment of FIG. 10, parallel to the elevation view of FIG. 10.

DETAILED DESCRIPTION

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structures. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention.

It is known in the art that oral bacteria cannot survive when exposed tolow-microampere direct current electricity. This method of killing oralbacteria and treating bacteria-caused conditions such as gingivitis hasbeen demonstrated in Nachman, U.S. Pat. No. 4,244,373 of Jan. 13, 1981and in Detsch, U.S. Pat. No. 4,509,519 of Apr. 9, 1985. Killing oralbacteria has the added benefit of preventing tooth decay and dentalcaries, or cavities. Generally, tooth decay is attributed to aerobicacid-producing bacteria whose acid causes uncompensated demineralizationof the teeth. However, Nachman does not instruct optimal approaches toreducing oral bacteria including aerobic and anaerobic bacteria on aspecies-by-species level and instead teaches a generic, untargetedtreatment.

It has been discovered that by delivering a current level in theapproximate range of 50 to 250 microamperes, a direct current electricaltreatment is able to deliver new and unexpected therapeutic,prophylactic, and regenerative benefits previously unknown in the art.

Specifically, by utilizing a direct current in the aforementioned range,not only can such a treatment kill bacteria, but it can also kill ordisable viruses and fungus as well. Studies from the podiatric fieldhave shown that higher current levels than those used in existing oralelectrical treatments are necessary to effectively treat fungalinfections (“Low-Voltage Direct Current as a Fungicidal Agent forTreating Onychomycosis”, Kalinowski, et al., Journal of the AmericanPodiatric Medical Association Vol. 94 No. 6: 565-572, 2004). Thus,fungicidal and viricidal benefits have been additionally provided inconjunction with a method already known to be bactericidal. Studies haveshown that these microbicidal properties begin to take effect withinapproximately 5 and 15 minutes of treatment, reducing both supra- andsub-gingival microbes.

In addition, clinical research has demonstrated that a direct current inthe approximate range of 50 to 250 microamperes was able to regenerategingival tissues, providing a non-surgical treatment alternative forthose with recessed gums. While the osteogenic properties of electricityhave been known in the art, the connection between nonosseous tissueregeneration and electricity were not well known in the art prior tothese experiments. The unique current range associated with the methodand apparatus of this invention is one of a few effective methods inanimal the dental field to accomplish effective gingival tissueregeneration in a non-surgical manner.

In further research, testing has examined the effects of direct currentstimulation on three different oral bacteria (F. nucleatum, S. oralis,P. gingivalis) in both saline and saliva solutions. This testing variedthe current levels, inoculum size of bacteria, solution medium, andtreatment time to develop an optimal treatment to reduce these threebacteria species associated with both periodontal and systemic diseases.

The results of this testing showed that each different bacterium had adifferent dose response to DC stimulation. Through this testing,treatment parameters have been identified that were able to kill up to100% of S. oralis, 99.1% of F. nucleatum, and 52.3% of P. gingivalis ina single treatment lasting thirty minutes or less. This research yieldedspecifications for DC-based treatments of targeted pathogens that waspreviously unknown in the art. The optimal treatment parametersdiscovered in this research and described in this method can provide aninnovative way to reduce these three species of bacteria, in both supra-and sub-gingival environments, and thus prevent and/or treat theirassociated complications including periodontal disease, biofilmformation, as well as the systemic diseases correlated to these oralpathogens.

In addition, scanning electron microscopy (SEM) has been conducted on F.nucleatum colonies before and after a 30 minute treatment to betterunderstand the mechanism by which the method according to this inventionis able to reduce bacterial levels. The SEM imagery suggested that themethod according to this invention interferes with bacterial cellulardivision and can weaken the outer envelope (cell membrane) resulting infragile cellular structures that can easily break. It is contemplatedthat this is phenomenon is an example of electroporation, where thepermeability of cellular membranes may be affected by electricalstimulation either temporarily or permanently. It is furthercontemplated that the electroporation caused by the method according tothis invention could play a role in developing new therapies inmolecular biology which would take advantage of this cellularpermeability and introduce new material into the cells of oral pathogensor oral tissues through mechanisms including, but not limited to geneticmaterial (transfection) such as DNA, RNA, sRNA, siRNA, plasmids, etc.These effects would prove a new tool in targeted gene therapies for oralapplications.

Specifically, devices according to the present invention may be used toreduce viable colony forming units (CFU) in various oral bacteria.

An embodiment 100 of an animal treatment apparatus is shown in FIGS.1-8. The treatment apparatus 100 generally includes a body 110 extendinglongitudinally between and including a first end 112 and a second end114 opposite the first end 112. The body 110 is preferably a generalhourglass shape. While the hourglass shape could be provided in avariety of fashions, a preferred structure includes the outwardappearance of a plurality (e.g., at least three) of circumferentialridges 116 defined by a plurality of stacked toroids. While the term“toroid” is utilized to describe the general outward appearance ofportions of the body 110, it is understood that the internalconstruction of the body 110 may not include corresponding toroidalconfigurations. With reference momentarily to FIG. 7, it should beappreciated that the “toroid” language generally describes a ridge 116having a continuous curved outer surface of a preferred radius R,wherein such radius R extends from a centerpoint C that resides on acircle which extends about a central longitudinal axis A of the body110. A first circumferential ridge 116 a is preferably disposed at ornear a longitudinal midpoint of the body 110. This circumferential ridge116 a has a first ridge diameter (118 a in FIG. 7), which may be thesmallest of any of the ridges 116. A second circumferential ridge 116 bis preferably disposed at the second end 114 of the body 110. Thiscircumferential ridge 116 b has a second ridge diameter (118 b in FIG.8), which is larger than the first ridge diameter 118 a, and it furthermay be the largest diameter of any of the ridges 116. A thirdcircumferential ridge 116 c is preferably disposed at the first end 112of the body 110. This circumferential ridge 116 c has a third ridgediameter (118 c in FIG. 7), which is larger than the first ridgediameter 118 a, and it may be the same as or smaller than the secondridge diameter 118 b.

On the body 110, preferably extending radially outward from the secondcircumferential ridge 116 b may be one or more handle anchors 120. Theanchors 120 preferably provide a location at which to, for example, docka flexible handle 122, such as a rope. The rope 122 may be insertedthrough the anchor 120, such as through an aperture (124 in FIG. 7)formed at least partially in the anchor 120, and possibly partially intothe second circumferential ridge 116 b. The rope 122 could then beprovided with a slip-stop 126, such as a knot or aglet. Where more thanone anchor 120 is provided, the plurality of anchors 120 is preferablyequally spaced about a circumference of the body 110 extending about thelongitudinal axis A.

One or more cavities may extend inwardly from an exterior surface of thebody 110. A first cavity 128 extends into the body 110 from the firstend 112. The cavity 128 is preferably formed symmetrically about thelongitudinal body axis A, extending into the body 110 for a preferreddepth, which may be less than half of the longitudinal length of thebody 110, which extends between and includes the first end 112 and thesecond end 114. The cavity 128 extends from an aperture 130 formed inthe first end 112 to a closed end 132 disposed within the body 110. Theaperture 130 extends about a diameter 134 defined by an annular ridge136, and the cavity 128 expands outwardly to a second, larger diameter138 on the inside of the ridge 136. Extending further inward, the cavity128 is defined by a substantially frustoconical wall 140, ending with aterminal diameter 142, which is preferably smaller than both theaperture diameter 134 and the larger diameter 138. A second cavity 144may also be provided in the body 110. The second cavity 144 may extendinto the body 110 from the second end 114, and may be provided as acylindrical or a stepped reentrant bore. The second cavity 144 extendsinto the body 110 for a preferred depth, but preferably does not extendso far as to intersect the first cavity 128. If the body 110 is providedwith a first cavity 128 and a second cavity 144 as described, they arepreferably separated by a divider 146, which is preferably a solid,non-conductive divider formed of the same nonconductive material as amajority of the body 110.

At least two electrodes, one cathode 150 and one anode 160, are providedand electrically accessible on the material forming the outer surface ofthe device 100. On an external surface of at least one of the ridges116, a cathodic electrode element 150 is provided. On an externalsurface of at least one of the ridges 116, an anodic electrode element160 is provided. The body 110 is generally formed from a first,electrically insulative material 170 and a second, electricallyconductive material 180. The insulative material 170 may be injectionmolded from a desirable material in a first mold, which may include aremovable insert defining wells 172 to receive the conductive material180 after the insulative material 170 is cured. The conductive material180 is placed into electrical communication with the electronics module148 through one or more connection passages 174. The wells 172preferably have a radial surface area that is larger than thelongitudinal cross-sectional area of the connection passage 174. Theconductive material 180 is preferably exposed within the second cavity144 through the connection passage 174. Alternatively, a wire (notshown) or other electrical connection could be used. Preferably, theconductive material 180 comprises a resilient material (preferablydurometer Shore A range of about 25 to about 80, or even up to about90-95) to encourage chewing of the treatment apparatus 100. Asnon-limiting examples, a conductive silicone, urethane, fluorosilicone,or other conductive polymer or a conductive fabric (e.g. silver-platednylon, or non-woven conductive or conductive-through-adhesive fabrictape) may be used as, or as a part of, the covering material. Regardlessof the covering material used, it is preferred that at least a portionof the material forming the outer surface of the apparatus conductselectricity from the power supply, or regulated amount thereof, to theanimal's mouth. The conductive material portions 180 are preferablyseparated by non-conductive material 170, such as an insulative polymer(e.g. non-conductive silicone) or fabric, preferably havingapproximately the same durometer Shore A hardness as the conductivematerial, or a similar tooth feel thereto. Alternatively, in anotherpreferred embodiment, the hardness of the non-conductive material 170 isless than that of the conductive material 180, such as about half. Whilethe conductive material 180 may be disposed in the wells 172, the device100 is preferably provided with a substantially or completelyimperforate radial outer surface.

The cathodic electrode 150 may be formed into a variety ofconfigurations, but a preferred configuration includes a cathodic stemportion 152, from which one or more cathodic branches 154 extend. Thecathodic stem 152 preferably extends along a majority of the length ofthe body, generally parallel to the longitudinal axis A. The cathodicbranches 154 are preferably formed integrally with the stem 152, butpreferably extend annularly from the stem 152, more preferably beingdisposed on the radially outermost surface of respective ridges 116 ofthe body 110. As indicated, separated from the cathodic electrode 150 byinsulative material 170 is an anodic electrode 160. A preferred anodicelectrode configuration includes an anodic stem portion 162, from whichone or more anodic branches 164 extend. The anodic stem 162 preferablyextends along a majority of the length of the body, generally parallelto the longitudinal axis A. The anodic stem 162 may be diametricallyopposed from the cathodic stem 152. The anodic branches 164 arepreferably formed integrally with the anodic stem 162, but preferablyextend annularly from the anodic stem 162, more preferably beingdisposed on the radially outermost surface of respective ridges 116 ofthe body 110. A plurality of ridges 116 preferably includes a cathodicbranch 154 and an anodic branch 164 on each ridge 116. It should benoted that alternative shapes and configurations that maintain a spacedcathodic electrode 150 and anodic electrode 160 configuration are withinthe scope of the present invention. For instance, if the device 100 isprovided with two anchors 120, which are diametrically opposed from oneanother, while the electrode stems 152,162 may be disposedlongitudinally in line therewith, it is preferred to have the stems152,162 longitudinally offset by some predetermined number of degrees,such as about 90 degrees, as shown.

Turning now to FIGS. 6-9, disposed within the second cavity 144 may bean electronics module 148, which is preferably sealed water-tight, andhouses a circuit 200 shown in FIG. 9. The circuit 200 generally includesa control board 210 and a power supply 230. The control board 210 andpower supply 230 may be of any types known to provide an ability totransfer the power of the power supply 230 to the electrodes 150 and160, which were previously described. Fully contemplated within thepurview of the present invention to be included in the circuit 200 aretimers, audible (e.g., sounds representative or imitative of a mousesqueak or bird chirp), tactile/haptic (e.g. vibrations provided by avibratory motor such as a coin or pancake vibration motor), and/orvisible prompts or feedback, or usage, activity and/or power indicators(e.g. beeper, buzzer, light-emitting diodes), motion activation (e.g.using an accelerometer), moisture activation, pressure activation,electrical current intensity adjustment (e.g., based on sensed impedancebetween a cathode 150 and an anode 160), and/or an on/off switch 232 tocontrol the possible current delivery by the power supply 230.Optionally, a programmable microcontroller (or a pre-programmed ASIC)could be used, as previously described, to control the various functionsprompts/feedback and could record various treatment parameters and/ortreatment history in non-volatile memory to be analyzed in real-time orpost-treatment. If a programmable microcontroller is utilized, aprogramming interface may be provided, such as a wired (e.g., UniversalSerial Bus) or a wireless (e.g., Bluetooth®, WiFi (e.g., IEEE 802.11),infrared, etc.) interface to allow programming of the microcontroller,thereby enabling it to control the operation of the device. Parametersthat may be desirably programmed may be electrical stimulation intensity(e.g. current level) and/or the frequency and type of prompts and/orfeedback. The power supply 230 may be a simple dry-cell battery, arechargeable battery, a capacitor, a kinetic energy generator, apiezoelectric generator, a microcontrolled DC power supply, or otherpower supply (such as a microcontrolled AC power supply). Regardless ofthe power supply 230 used, it is most preferable to control the amountof electrical current delivered by the treatment device to provide arelatively constant current power source to provide up to about 500microamps of direct or alternating current. While 50 microamps to about500 microamps may be a desired range, about 50 microamps to about 250microamps is preferred, and about 100 microamps is still furtherpreferred. Such control may be provided by a microcontroller or discretemonitoring circuitry (such as through current and/or impedance sensing),or optimal dry-cell design if expected impedances are generally known.It is further contemplated by the present invention that the treatmentapparatus 100 is preferably used by non-human animals, such as felines,bovines, ovines, canines, equines, porcines, etc. Power supplies andother circuit components may be found in published U.S. patentapplication Ser. No. 13/839,513, which is incorporated herein byreference in its entirety.

A circuit will be completed by an animal's mouth when the device 100 ismasticated. This is schematically represented in FIG. 9 by impedancesRo, provided by the animal's mouth (e.g. saliva and/or oral tissues),extending between two or more electrodes. The circuit 200 containedwithin the electronics module 148 may be coupled to the conductivematerial 180 forming the electrodes 150,160 by exposed electricalconductors supported by the module 148 which are placed in frictionalcontact with the conductive material 180 when the module 148 is insertedinto and supported within the second cavity 144. Preferably, electricalconductors that interface between the power supply 230 and theelectrodes 150,160 extend from the power supply 230 in the samedirection. That is, a first electrical conductor that couples thecathodic electrode 150 to the positive pole of the power supply 230preferably extends from the positive pole in a first longitudinal orradial direction. A second electrical conductor that couples the anodicelectrode 160 to the negative pole of the power supply 230 preferablyextends from the negative pole in the same longitudinal or radialdirection as the first electrical conductor. Of course, the coupling ofthe electrodes 150,160 to the power supply 230 is not required to be adirect coupling, but rather may be indirect coupling through a varietyof other electrical passive or active electrical components, such as oneor more voltage regulators, operational amplifiers, transistors,microcontrollers, voltage converters/inverters, etc. Regardless of thespecific circuit design, it is preferable that the circuit 200 be ableto supply a stimulation (pulsed or steady) current of about 50 microampsto about 500 microamps to a load (Ro) of up to about 70 kilo-ohms. Morepreferably, to such load, a stimulation current of about 50-250microamps, and still more preferably, a current of about 100 microampshas been shown to be effective.

FIGS. 10 and 11 depict features of a second embodiment 200 of a deviceaccording to the present invention, where similar reference numeralsrefer to substantially similar or identical structure as described withrespect to the first embodiment 100. Like the first embodiment one ormore cavities may extend inwardly from an exterior surface of the body210. A first cavity 228 extends into the body 110 from the first end212. The cavity 228 is preferably formed symmetrically about thelongitudinal body axis A, extending into the body 210 for a preferreddepth, which may be less than half of the longitudinal length of thebody 210, which extends between and includes the first end 212 and thesecond end 214. The cavity 228 extends from an aperture 230 formed inthe first end 212 to a closed end 232 disposed within the body 210. Theaperture 230 extends about a diameter 234 defined by an annular ridge236, and the cavity 228 expands outwardly to a second, larger diameter238 on the inside of the ridge 236. Extending further inward, the cavity228 is defined by a substantially frustoconical wall 240, which may beribbed or textured, ending with a terminal diameter 242, which ispreferably smaller than both the aperture diameter 234 and the largerdiameter 238. A second cavity 244 may also be provided in the body 210.The second cavity 244 may extend into the body 210 from the second end214, and may be provided as a cylindrical or a stepped reentrant bore.The cavity 244 may include a retaining lip 245 adapted to maintain theelectronics module 248 generally securely within the cavity 244. Thesecond cavity 244 extends into the body 210 for a preferred depth, whichmay be greater than half of the length of the body 210 along the axis A,but preferably does not extend so far as to intersect the first cavity228. If the body 210 is provided with a first cavity 228 and a secondcavity 244 as described, they are preferably separated by a divider 246,which is preferably a solid, non-conductive divider formed of the samenonconductive material as a majority of the body 210.

Also like the first embodiment 100, this embodiment 200 includes atleast two electrodes, one cathode 250 and one anode 260, provided andelectrically accessible on the material forming the outer surface of thedevice 200. The stem portions 252, (262 not shown) of this embodiment200 are serpentine, rather than being substantially linear like the stemportions 152,162 on the first embodiment 100. Additionally, thisembodiment 200 includes one or more ruts 290 adapted to receive anedible substance (e.g. canned dog food or nutrient gel) or a dentifrice.The ruts 290 preferably extend radially about the body 210 for apredetermined length or about a predetermined angle (e.g. 30-60 degrees)about the axis A.

Treatment of Non-Human Animals

A method according to the present invention may be used for promotingoral hygiene in non-human animals, such as felines, bovines, ovines,canines, porcines, and/or equines. The method comprises the steps ofproviding a treatment apparatus comprising a power source and aplurality of electrodes electrically coupled to the power source. Thepower source may be an internal direct current power source, or otherpower source as described above. The plurality of electrodes includes atleast one, but preferably a plurality of cathodic electrodes and atleast one, but preferably a plurality of anodic electrodes. Theelectrodes may be positioned in a spaced arrangement about, andpreferably conductive through, the exterior of the treatment apparatusby a conductive material. The electrodes may be arranged in analternating cathodic/anodic fashion about the device. The method furthercomprises the step of providing such device to a non-human animal,thereby allowing delivery of electrical current from the power source,through the electrodes and to at least one of the animal's oralsecretions (e.g., saliva) and oral tissue (e.g., lingual tissue, dentaltissue, gingival tissue, periodontal tissue, and oral mucosa tissue).

Systems and methods according to the present invention may be used toreduce oral bacteria and/or biofilm, as well as to treat systemicdiseases that may be associated with oral bacteria, in non-humananimals, such as dogs, cats, sheep, horses, cows, pigs, etc.

For instance, periodontal disease is one of the most common healthproblems affecting dogs (>75%). The prevalence of periodontal diseasehas been found to increase age but decrease with body weight. Varioussystemic diseases have been suggested as a strong co-factor forperiodontal disease in animals, just as in humans. It has been suggestedthat periodontal disease could have a causal relationship with systemicdiseases in both humans and animals. For dogs, and animals in general,periodontitis is a recurrent and persistent disease and exposes the hostto negative systemic effects over an extended period of time, e.g.several years.

It has been observed that, over the course of several years, frequentexposure of bacteremia as a result of minor trauma at sites ofperiodontal inflammation may cause infection or induce inflammation atdistant sites with the body. The pathogenesis of periodontal disease indogs has been linked with gram-negative anaerobic bacteria uponaccumulation within the gingival sulcus causing inflammation and theformation of periodontal pockets. The inflammatory response toperiodontal pathogens promotes the formation and release of endotoxinsand inflammatory cytokines that can decrease functions of vital organsover time. It has been suggested that systemic diseases may beassociated with periodontal disease in dogs, including chronicbronchitis, pulmonary fibrosis, endocarditis, interstitial nephritis,glomerulonephritis, and hepatitis.

Periodontal organisms present in dogs with periodontitis have beenisolated and identified previously. For instance, the followingperiodontal pathogens have been found to be associated with periodontaldisease in dogs: P. gingivalis (64% of periodontitis-positive dogs), C.rectus, A. actinomycetemcomitans, P. intermedia, T. forsythensis, F.nucleatum (4% of periodontitis-positive dogs), E. corrodens, P.denticanis, P. gulae, P. salivosa. Recommended treatments using systemsand/or methods according to the present invention to treat and/orprevent periodontal disease by reducing or controlling such types ofbacteria, may include a predetermined time, such as 20 minutes, of oralsecretions and/or tissue (i.e., saliva, lingual tissue, dental tissue,gingival tissue, periodontal tissue, and/or oral mucosa tissue) exposureto an electrical current (alternating or direct current, constant orpulsed) level of between about 50 microamps (μA) and about 500 microamps(μA), with about 50 microamps to about 250 microamps being preferred,and about 100 microamps being still further preferred. Devices accordingto the present invention have been shown to be effective at reducing thecount of bacterial species in this current range.

As with dogs, periodontal disease in cats is associated with localinflammation and is purported to influence and induce systemic responsesand organ function in distal sites. One of the common oral pathogensfound in the oral cavity of cats is P. gingivalis. Studies havedemonstrated that indeed measureable systemic changes arise during theprogression of periodontal disease, such as increased levels of serumIgG. Further, these levels could be altered with periodontal treatment.Recommended treatments using systems and/or methods according to thepresent invention to treat and/or prevent periodontal disease in cats byreducing or controlling such types of bacteria, may include apredetermined time, such as 20 minutes, of oral tissue exposure to anelectrical current (alternating or direct current, constant or pulsed)level of between about 50 microamps (μA) and about 500 microamps (μA),with about 50 microamps to about 250 microamps being preferred, andabout 100 microamps being still further preferred. Devices according tothe present invention have been shown to be effective at reducing thecount of such bacterial species in this current range.

Periodontitis may also be found in sheep and cattle, also referred to as“broken mouth”, and is associated with severe degradation of periodontalcollagen, loss of alveolar bone, appearance of periodontal pockets andpremature tooth loss. Although morphological and histologicaldifferences exist between the periodontium of sheep, cattle, and humans,the histopathological appearance is similar in periodontal disease,including the role that P. gingivalis plays in the progression of thedisease. Recommended treatments using systems and/or methods accordingto the present invention to treat and/or prevent periodontal disease insheep and/or cattle by reducing or controlling such types of bacteria,may include a predetermined time, such as 20 minutes, of oral tissueexposure to an electrical current (alternating or direct current,constant or pulsed) level of between about 50 microamps (μA) and about500 microamps (μA), with about 50 microamps to about 250 microamps beingpreferred, and about 100 microamps being still further preferred.Devices according to the present invention have been shown to beeffective at reducing the count of such bacterial species in thiscurrent range.

Cardiovascular-related conditions may also exist in non-human animals.For instance, there has in dogs been revealed an association betweenperiodontal disease severity and risk of cardiovascular-relatedconditions, such as endocarditis and cardiomyopathy. Endocarditis is aresult of infection and inflammation of the heart endothelium, or tissuelining the inner surface of the heart valves and can be caused byvarious microorganisms. Cardiomyopathy is characterized by an enlargedheart that does not function properly. Both diseases carry a poorprognosis based on the severity of the case. For dogs, it has been foundthat the risk of endocarditis was 6-fold higher in dogs with stage 3periodontal disease than it was for healthy dogs and for cardiomyopathyit was about 4-fold. Cardiac disease progression may be affected by thepresence and/or prevalence of certain oral bacteria, including S.oralis, F. nucleatum, and P. gingivalis. Recommended treatments usingsystems and/or methods according to the present invention to treatand/or prevent cardiac disease by reducing or controlling such types ofbacteria, may include a predetermined time, such as 20 minutes, of oraltissue exposure to an electrical current (alternating or direct current,constant or pulsed) level of between about 50 microamps (μA) and about500 microamps (μA), with about 50 microamps to about 250 microamps beingpreferred, and about 100 microamps being still further preferred.Devices according to the present invention have been shown to beeffective at reducing bacterial burden of all three species in thiscurrent range.

In addition to cardiac disease, a prior retrospective longitudinal studyhas established a relationship between periodontal disease and chronickidney disease (CKD). The hazard ratio of CKD in dogs, in conjunctionwith increased serum creatinine and blood urea nitrogen concentrations,has been shown to increase, with increasing severity of periodontaldisease, from stage 1 to stage 4, thereby establishing a significantpositive association between periodontal disease and CKD.

Both F. nucleatum and P. gingivalis are common oral pathogens presentedin dogs, and may be linked to kidney disease. Accordingly, reduction ofsuch pathogens may be used as a treatment or prevention thereof.Recommended treatments using systems and/or methods according to thepresent invention to treat and/or prevent kidney disease by reducing orcontrolling such types of bacteria, may include a predetermined time,such as 20 minutes, of oral tissue exposure to an electrical current(alternating or direct current, constant or pulsed) level of betweenabout 50 microamps (μA) and about 500 microamps (μA), with about 50microamps to about 250 microamps being preferred, and about 100microamps being still further preferred. Devices according to thepresent invention have been shown to be effective at reducing the countof such bacterial species in this current range.

Non-human animal diabetes may also be treated and/or prevented usingsystems and methods according to the present invention. In humans, asstated, there is an established link between diabetes mellitus andperiodontal disease, and such a relationship has been suspected inveterinary medicine. One prior study has demonstrated that blood glucoseconcentrations are increased in relation to attachment loss andperiodontal disease state in dogs. Additionally, these levels decreasedfollowing periodontal disease treatment.

The S. oralis bacterium has been associated with severe periodontitisand diabetes. Recommended treatments using systems and/or methodsaccording to the present invention to treat and/or diabetes by reducingor controlling such types of bacteria, may include a predetermined time,such as 20 minutes, of oral tissue exposure to an electrical current(alternating or direct current, constant or pulsed) level of betweenabout 50 microamps (μA) and about 500 microamps (μA), with about 50microamps to about 250 microamps being preferred, and about 100microamps being still further preferred. Devices according to thepresent invention have been shown to be effective at reducing the countof such bacterial species in this current range. Such a reduction mayhelp combat high levels of blood glucose.

Furthermore, systems and methods according to the present invention maybe used to affect (preferably reduce and/or eliminate) the number oforal bacteria transferred between animals of different species, such asbetween a pet and its owner. It is well established that oral bacteria,including periodontal pathogens, can be transmitted between mothers andtheir children simply through everyday close contact. Therefore, it isnot unfounded that transmission of such bacteria may occur betweenhumans and their companion animals. One study investigated In fact, theprevalence of periodontal pathogen species in dogs and their owners toexamine the possibility of pet-to-owner transmission has been studied.P. gulae was detected in 71.2% of dogs in the study and 16% in theowners. Interestingly, P. gulae is extremely uncommon in the human oralcavity, and each owner who harbored the bacteria had a dog that testedpositive for the pathogen. Two additional species, E. corrodens and T.denticola, were found to correlate between owners and dogs indicatingthat oral bacteria species may be transmitted between dogs and theirowners.

The P. gulae bacterium, a member of the Porphyromonas genus found in theoral cavity of dogs, has been shown to share 60% homology with P.gingivalis. This suggests that P. gulae would respond similarly totreatment with the device as does P. gingivalis. Recommended treatmentsusing systems and/or methods according to the present invention toremedy and/or prevent the transfer of oral bacteria between animals ofdifferent species by reducing or controlling such types of bacteria, mayinclude a predetermined time, such as 20 minutes, of oral tissueexposure to an electrical current (alternating or direct current,constant or pulsed) level of between about 50 microamps (μA) and about500 microamps (μA), with about 50 microamps to about 250 microamps beingpreferred, and about 100 microamps being still further preferred. Eitheror both animals (e.g. a dog and/or its owner) may be so treated. Devicesaccording to the present invention have been shown to be effective atreducing the count of such bacterial species in this current range. Suchtreatment should reduce levels of P. gulae and diminish the possibilityof pathogen transmission to the animal's owner.

The treatment times may be a constant treatment time (e.g. 20consecutive minutes) or treatments may be prescribed and/or deliveredfor a predetermined period of time (e.g. 1-60 minutes) within atreatment window (e.g. 24 hours, one week, one month, etc.) in shorterincremental treatments, such as two minutes, five times a day (toachieve 10 minutes of stimulation within a treatment window of 24hours).

Thus, embodiments according to the present invention are able to achievemultiple prophylactic, therapeutic, and regenerative effects innon-human animals whose combination was not previously known oravailable in the art. Namely, these effects are: promotion of oralosteogenesis, destruction or disabling of oral microbes, gingival tissueregeneration, reduction and prevention of the formation of oralbiofilms, caries prevention, increased oral vasodilation and oral bloodflow, treatment of common oral conditions such as gingivitis andperiodontitis, treatment of systemic diseases and conditions correlatedwith oral pathogens, and generally improved oral hygiene.

These effects are accomplished by the delivery of direct current to theanimal's oral secretions and/or tissues through a plurality ofelectrodes. The electrodes may be fashioned out of anyelectrically-conductive material, including but not limited to metalssuch as silver, stainless steel, copper, gold, platinum, palladium,aluminum, an alloy thereof, electrically-conductive nanotubes,carbonized rubber, electrically-conductive silicone, orelectrically-conductive polymers. The electrodes may be composed of thesame or of differing materials.

Electrical conductors then couple these electrodes to an adjustablepower supply. All of the anodic electrodes will electrically communicatewith the positive pole of the power supply and all of the cathodicelectrodes will electrically communicate with the negative pole of thepower supply. The adjustable power supply is capable of delivering astable, direct current in the approximate range of 1 to 500microamperes. The preferred current setting for most treatments is inthe approximate range of 50 to 250 microamperes, with about 100microamps being still further preferred.

Thus, the reader will see that at least one embodiment herein addressesa desired need in the non-human animal oral hygiene and dental fields totreat common oral diseases and conditions in a more effective, lessinvasive, and less expensive manner. These embodiments promote generaloral hygiene, reduce oral biofilm, treat periodontal diseases such asgingivitis and periodontitis, kill oral microbes including bacteria andthus preventing cavities and tooth decay, increase vasodilation andblood flow in oral tissues, promote gingival tissue regeneration, fosterosteogenesis in the boney structures of the teeth, mouth, and relatedareas, treat systemic diseases related to oral pathogens, and treatother periodontal and oral maladies through the non-invasive applicationof weak direct current electricity to the surfaces in the oral cavity.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

We claim:
 1. A method comprising the steps of: providing a deviceincluding a body having an external surface formed of a firstelectrically insulative resilient material and a first and secondelectrically conductive resilient material, wherein the firstelectrically conductive resilient material is in electricalcommunication with a first pole of a power source disposed in the bodyand the second electrically conductive resilient material is inelectrical communication with a second pole of the power source; anddelivering the device to a mouth of a non-human animal to deliverbetween the first and second electrically conductive resilient materialan electrical current sourced from the power source for a predeterminedduration of time to reduce a bacterial concentration within the mouth.2. The method according to claim 1, wherein the electrical current issourced directly from the power source.
 3. The method according to claim1, wherein the electrical current is selected from the group consistingof alternating current and direct current.
 4. The method according toclaim 3, wherein the electrical current is one of constant and pulsed.5. The method according to claim 1, wherein the electrical current isprovided at a current level of between about 50 microamps (μA) and about500 microamps (μA).
 6. The method according to claim 5, wherein thecurrent level is about 50 microamps to about 250 microamps.
 7. Themethod according to claim 6, wherein the current level is about 100microamps.
 8. The method according to claim 1, wherein the body at leastpartially comprises an hourglass shape.
 9. The method according to claim1, wherein the first electrically insulative resilient material isdisposed between the first electrically conductive resilient materialand the second electrically conductive resilient material.
 10. Themethod according to claim 9, wherein the first electrically conductiveresilient material and the second electrically conductive resilientmaterial are the same composition of material.
 11. The method accordingto claim 10, wherein the first electrically insulative resilientmaterial has a first durometer hardness and the first and secondelectrically conductive resilient material have a second durometerhardness.
 12. A device according to claim 11, wherein the firstdurometer hardness is substantially the same as the second durometerhardness.